Medical Devices - New regulations

The procurement of MDs and IVDs

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The procurement ecosystem should be aware that products certified under the Directives and products certified under the Regulations will coexist on the market until May 2025. During this period both types of certification will have equal status under the law and no discrimination in public tenders may take place.

To avoid market disruption and allow a smooth transition from the Directives to the Regulations, several transitional provisions are foreseen in the Regulations, because the new Regulations require the designation of notified bodies and introduce more stringent requirements for manufacturers, particularly in terms of clinical evaluation.

Even after the transitional period, and under certain conditions, manufacturers may continue to place on the market until May 2024 products compliant with the Directives, and distributors may continue to make them available or put them into service until May 2025.

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